Home › RICHARD-ALLAN SCIENTIFIC COMPANY › Epredia
Epredia
RICHARD-ALLAN SCIENTIFIC COMPANY · Model 37% Formaldehyde · UDI-DI 00673693101004
10
510(k) clearances
40
Adverse events
2
Recalls
35
Facilities
Description
Formaldehyde is a colorless gas used in a 37-40% solution in water for tissue fixation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-13 | Richard-Allan Scientific Company | potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigen |
| 2008-05-01 | ThermoFisher Scientific Co., LLC | Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.